Senior Associate - Holly Springs, NC

Military Spouse Corporate Career Network•Holly Springs, NC

1d•Onsite

About The Position

Amgen is seeking a Senior Associate to join their Bulk Drug Substance Manufacturing Services team in Holly Springs, NC. This role is crucial for supporting the startup and operation of Amgen's newest and most advanced drug substance manufacturing plant, the FleX Batch facility. This facility will combine disposable technologies with traditional stainless-steel equipment, incorporating industry 4.0 capabilities and sustainability innovations to reduce carbon and waste, aligning with Amgen's goal of being a carbon-neutral company by 2027. The Senior Associate will play a key role in enabling manufacturing operations through various services, including weigh and dispense of raw materials, material receiving and handling, media, buffer, and solution preparation, and component preparation. The position offers the opportunity to make a lasting impact on patients' lives by contributing to the research, manufacturing, and delivery of innovative medicines.

Requirements

High School Diploma/GED + 4 years manufacturing and/or other regulated environment experience
OR Associate’s Degree + 2 years manufacturing and/or other regulated environment experience
OR Bachelor’s Degree + 6 months manufacturing and/or other regulated environment experience
OR Master's Degree

Nice To Haves

Completion of NC BioWorks Certification Program
Experience in biotechnology or pharmaceutical plant start up
Knowledge and process experience within a cGMP manufacturing facility or other highly regulated environment
Strong understanding of solution preparation, equipment preparation, and inventory control operations
Excellent verbal and written communication (technical) skills
Proficient Microsoft Office skills, and knowledge of other electronic systems such as EBR/MES, Delta V, and Electronic Quality Systems

Responsibilities

Provide technical and operational support to the Services area.
Coordinate daily activities within the Services team.
Support training and qualification of staff.
Promote safe, compliant, and reliable execution of operations.
Partner across functions to support operational readiness, technology transfer, facility startup, and ramp-up of manufacturing operations.
Complete work in accordance with established cGMP procedures and policies (SOPs, MPs, JHAs, CFR) with strict adherence to safety and compliance.
Initiate deviation reports.
Interact with regulatory agencies as needed and guided.
Assure proper gowning and aseptic techniques are always followed.
Perform hands-on operations including set-up, cleaning, sanitization, and monitoring of equipment and assigned area.
Run and monitor critical process tasks per assigned procedures.
Perform in-process sampling, operate analytical equipment, and complete process documentation (Electronic Batch Records [EBR]).
Complete washroom activities: cleaning equipment, small to large scale, used in production activities.
Identify, recommend, and implement innovative process improvements and optimizations related to daily routine functions.
Assist in the review of documentation for assigned functions (i.e., equipment logs, EBRs).
Collaborate as part of a cross-functional team (i.e., QA/QC, F&E, PPIC, Mfg., PD, Regulatory, etc.) in completing production activities.
Recognize and elevate problems during daily operations.
Participate in the implementation of programs and CAPAs with an eye toward continuous improvement.
Drive safety in all operations, and assist the manager in escalating concerns as needed.
Maintain an organized, clean, and workable space.
Draft and revise documents (SOPs, technical reports, and MPs).
Interact with management as an advisor in planning and in escalating potential concerns with the schedule and/or process.